FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
1376–1400 of 7095
Cleared Aug 18, 2009
S. AUREUS PNA FISH
K091827 · Advandx, Inc.
NXX · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus · 60d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · Binax, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 20d
Cleared Aug 05, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
K082329 · Viramed Biotech AG
LSR · Reagent, Borrelia Serological Reagent · 356d
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · Advandx, Inc.
OAH · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis · 282d
Cleared Jul 24, 2009
RAMP RSV ASSAY
K091235 · Response Biomedical Corp.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 88d
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 526d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · Siemens Healthcare Diagnostics
LTT · Panels, Test, Susceptibility, Antimicrobial · 83d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 98d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109 · Cepheid
LLH · Reagents, Clostridium Difficile Toxin · 84d
Cleared Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · Bio-Rad Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 93d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 338d
Cleared Jun 25, 2009
XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
K091667 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 16d
Cleared Jun 18, 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d
Cleared Jun 08, 2009
SERAQUEST EBV EA-D IGG TEST
K091260 · Quest Intl., Inc.
LSE · Epstein-barr Virus, Other · 40d
Cleared Jun 05, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090971 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 60d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · Trek Diagnostic Systems, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 59d
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 68d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · Meridian Bioscience, Inc.
LQP · Campylobacter Spp. · 72d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 62d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K090409 · Bio-Rad Laboratories
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 79d
Cleared May 05, 2009
GBS PNA FISH
K082612 · Advandx, Inc.
OAH · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis · 238d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 88d
Cleared May 01, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K083088 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 197d
Cleared Apr 16, 2009
PROGASTRO CD ASSAY
K090239 · Prodesse, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 73d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87